NCT00869622|CompletedPhase 4ResultsDMC
Antiepileptic Drugs and Osteoporotic Prevention Trial
ADOPT
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Sponsor study identifier
interventional
80
1 country
1
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
January 2013
Actual (reported)Study Design: (e.g., Controlled, Double-Blind, Randomized, Parallel): Randomized, double-blind, placebo controlled of a bisphosphonate in the prevention of bone loss associated with the use of antiepileptic drugs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
March 25, 2009
Actual (reported)March 26, 2009
Actual (reported)October 2012
Actual (reported)January 2013
Actual (reported)July 24, 2015
Actual (reported)Changes in Bone Mineral Density
Patients with a T-Score of \> -2.5 were randomized into two possible arms. A bisphosphonate group received 35mg risedronate weekly while another group received an identical placebo tablet weekly. Both groups received supplemental calcium and vitamin D. Enrolled patients had bone density measurements of bilateral proximal femur, A-P lumbar spine, total body, forearm and L-P spine. All measurements were performed on a GE Lunar Bone Densitometer (iDXA) instrument. Measurements of 25-hydroxy vitamin D, NTX , serum calcium and blood chemistries occurred at scheduled intervals.
2 years
Vertebral Fractures
2 years
Active drug
All patients both on placebo and active bisphosphonate to receive calcium and vitamin D
35 mgs/week + calcium and vit d
sugar pill + calcium 1200mgs/day and vitamin d at least 800IU
VA Boston Healthcare System
Boston, Massachusetts, 02130, United States
Antonio A Lazzari, MD
VA Boston HCS
Phillip Dussault, Pharm D
VA Boston HCS
Manisha Thakore, MD
VA Boston HCS
80 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2009
First Posted
March 26, 2009
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
ROSPA - Record on Satisfaction of Patients With Actonel 35 mg Once a Week
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Primary Completion
October 2012
Actual (reported)Study Completion
January 2013
Actual (reported)Last Updated
July 24, 2015
Results First Posted
July 24, 2015
Record last verified: 2015-07
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Source: ClinicalTrials.gov.
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